Oxytocin
Generic: OXYTOCIN
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
6d7d1280-f286-4f39-89f3-2b96571810e6
Indications & Usage
INDICATIONS AND USAGE IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor.
Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction.
Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.
Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.
It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.
In the first trimester, curettage is generally considered primary therapy.
In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus.
Other means of therapy, however, may be required in such cases.
Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.
It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.
In the first trimester, curettage is generally considered primary therapy.
In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus.
Other means of therapy, however, may be required in such cases.
Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction.
Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.
Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.
It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.
In the first trimester, curettage is generally considered primary therapy.
In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus.
Other means of therapy, however, may be required in such cases.
Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons.
It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, pre-eclampsia at or near term, when delivery is in the best interest of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) adjunctive therapy in the management of incomplete or inevitable abortion.
In the first trimester, curettage is generally considered primary therapy.
In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus.
Other means of therapy, however, may be required in such cases.
Postpartum Oxytocin injection (synthetic) is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
Warnings
WARNINGS Oxytocin injection (synthetic) when given for induction or stimulation of labor, must be administered only by the intravenous route and with adequate medical supervision in a hospital.
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus.
The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug.
Severe water intoxication with convulsions and coma has occurred and is associated with a slow oxytocin infusion over a 24-hour period.
Maternal death due to oxytocin-induced water intoxication has been reported.
The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: • Bradycardia • Premature ventricular contractions and other arrhythmias • Permanent CNS or brain damage • Fetal death Due to use of oxytocin in the mother: • Neonatal retinal hemorrhage • Low Apgar scores at five minutes • Neonatal jaundice
The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus.
The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug.
Severe water intoxication with convulsions and coma has occurred and is associated with a slow oxytocin infusion over a 24-hour period.
Maternal death due to oxytocin-induced water intoxication has been reported.
The following adverse reactions have been reported in the fetus or infant: Due to induced uterine mobility: • Bradycardia • Premature ventricular contractions and other arrhythmias • Permanent CNS or brain damage • Fetal death Due to use of oxytocin in the mother: • Neonatal retinal hemorrhage • Low Apgar scores at five minutes • Neonatal jaundice